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Commerce and Industry Minister Anand Sharma, on Monday, raised concerns over the audit inspections of Indian pharma companies by the U.S Food and Drug Administration (USFDA) and said that India would soon submit a discussion document on the issues to the U.S. “We are going to give a non-paper (to the US) overall on some of our concerns, when it comes to duration for the...

Japanese companies do not mind erring on the side of caution. They are known to think longer and harder than their counterparts in other countries about big decisions, especially when it comes to entering a new market or acquiring a foreign company. But Japan's third biggest drugmaker Daiichi Sankyo would now wish it had spent more time doing due diligence on Ranbaxy Labs, in...

Sun Pharma Advanced Research Company (SPARC) on Saturday said the U.S. health regulator had not approved its new drug application for anti-glaucoma eyedrop. The product is to be manufactured at Sun Pharmaceutical Industries’ Halol facility and the USFDA has indicated that a satisfactory resolution of the current good manufacturing practice (cGMP) deficiencies at this facility...

Tablets embedded with ‘black fibre’ that was suspected to be hair from an employee’s arm, ‘black spots’ of oil from machines in tablets and absence of running water in toilets were some observations made by the US Food and Drug Administration (USFDA) that has banned import of drugs made at Ranbaxy’s Mohali unit. According to USFDA documents sent to Ranbaxy’s Mohali plant head...

Tablets embedded with ‘black fibre’ that was suspected to be hair from an employee’s arm, ‘black spots’ of oil from machines in tablets and absence of running water in toilets were some observations made by the US Food and Drug Administration (USFDA) that has banned import of drugs made at Ranbaxy’s Mohali unit. According to USFDA documents sent to Ranbaxy’s Mohali plant head...

New Delhi: Tablets embedded with 'blackfibre' that was suspected to be hair from an employee's arm, 'black spots' of oil from machines in tablets and absence of running water in toilets were some observations made by USFDA that has banned import of drugs made at Ranbaxy's Mohali unit. According to USFDA documents sent to Ranbaxy's Mohali plant head after a series of inspections...

Ranbaxy, which on Monday said that it did not receive any letter regarding import warning from the US Food and Drug Administration, on Tuesday confirmed having received such letter. In a communication to the BSE, the company said that during the late hour of September 16 (Monday), it received a communication from the USFDA that the regulator has imposed an import alert on its...

U.S. FDA’s Food Safety Modernization Act - How does it affect your business?

published:20 Feb 2015

U.S. FDA’s Food Safety Modernization Act - How does it affect your business?

U.S. FDA’s Food Safety Modernization Act - How does it affect your business?

published:20 Feb 2015

views:396

The U.S. Food Safety Modernization Act (FSMA) represents a major reform of the food safety regulations in the United States of America (USA). What are the new regulatory requirements under FSMA? How is your organization affected by these regulations? This webinar uncovers requirements under the new regulations and shares information on how these regulations will impact the food produced, imported into and exported to USA....

U.S. FDA’s Food Safety Modernization Act - How does it affect your business?

published:20 Feb 2015

views:396

The U.S. Food Safety Modernization Act (FSMA) represents a major reform of the food safety regulations in the United States of America (USA). What are the new regulatory requirements under FSMA? How is your organization affected by these regulations? This webinar uncovers requirements under the new regulations and shares information on how these regulations will impact the food produced, imported into and exported to USA....

The U.S. Food Safety Modernization Act (FSMA) represents a major reform of the food safety regulations in the United States of America (USA). What are the new regulatory requirements under FSMA? How is your organization affected by these regulations? This webinar uncovers requirements under the new

Course Description:
This 2-part course covers the significant events that led up to the creation of the Bioresearch Monitoring Program at US FDA, as well as its organizational structure, how the BIMO inspections are assigned, managed, and followed up.
Learn more at: http://www.wmdo.org/course-deta

Course Description:
According to the FDA’s Quality System Regulation (QSR) for medical devices, all manufacturers are required to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. But what are the important requirem